EVOLUT FX PLUS VALVE
Report
- Report Number
- 9617601-2025-00862
- Event Type
- Injury
- Date Received
- August 7, 2025
- Date of Event
- July 30, 2025
- Report Date
- August 21, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- NPT
- UDI-DI
- 00763000957377
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTED B.3 CORRECTION: THE CORRECT AWARE DATE FOR THIS EVENT IS 2025-07-30. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CORRECTED DATA: THE LOT NUMBER OF THE CONCOMITANT MEDTRONIC DEVICE WAS INADVERTENTLY OMITTED FROM SUPPLEMENTAL 001. CONTINUATION OF D10; OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: MEDTRONIC PRODUCT ID: D-EVOLUTFX-34; LOT#: 0012628475; PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED DATA: B5. A SECOND PARAGRAPH WAS ADDED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10; OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: MEDTRONIC PRODUCT ID: D-EVOLUTFX-34; LOT #: UNKNOWN; PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: NON-IMPLANTABLE NON-MEDTRONIC PRODUCT ID: 20MM NON-MEDTRONIC BECTON, DICKINSON AND COMPANY TRUE BALLOON; LOT #: UNKNOWN; UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: 22MM NON-MEDTRONIC BECTON, DICKINSON AND COMPANY TRUE BALLOON; LOT #: UNKNOWN; UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: 28MM BECTON, DICKINSON AND COMPANY TRUE BALLOON; LOT #: UNKNOWN; UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: 10X40MM ABBOTT ARMADA 35 BALLOON; LOT #: UNKNOWN; UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: 18MM NUMED BALLOON; LOT #: UNKNOWN; UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: 28MM NUMED BALLOON; LOT #: UNKNOWN; UBD: UNKNOWN X2 NON-MEDTRONIC PRODUCT ID: 22FR GORE MEDICAL DRYSEAL SHEATH; LOT #: UNKNOWN; UBD: UNKNOWN NON-MEDTRONIC PRODUCT ID: COOK MEDICAL LUNDERQUIST GUIDEWIRE; LOT #: UNKNOWN; UBD: UNKNOWN SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN THE REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED PRIOR TO A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE REPLACEMENT PROCEDURE, THE PATIENT WAS INTUBATED. VASCULAR ACCESS WAS ACHIEVED VIA THE RIGHT FEMORAL ARTERY. TEMPORARY TRANSVENOUS PACING WAS INITIATED AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION. AT THE START OF THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A 28MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON WAS INSERTED AND NAVIGATED TO THE HEART FOR A PRE-IMPLANT BALLOON DILATION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE AORTIC VALVE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND REPLACED WITH A 10X40MM NON-MEDTRONIC (ABBOTT ARMADA 35) BALLOON. FOLLOWING THE PRE-IMPLANT BALLOON DILATION, THE 18MM NON-MEDTRONIC (NUMED) BALLOON RUPTURED. WHEN THE 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH WAS WITHDRAWN FROM THE PATIENT, NO REMNANTS OF THE RUPTURED PORTION OF THE BALLOON WAS IN THE SHEATH. A NEW 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH WAS INSERTED INTO THE PATIENT. A 22MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON WOULD NOT CROSS THE AORTIC VALVE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND A SMALLER 20MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON SUCCESSFULLY CROSSED THE AORTIC VALVE AND A PRE-IMPLANT BALLOON DILATION WAS PE RFORMED. THEN A SERIAL DILATION WAS PERFORMED WITH NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOONS: A 22MM FOLLOWED BY A 28MM. THE 18FR MEDTRONIC INLINE SHEATH AND DELIVERY CATHETER SYSTEM (DCS) WERE INSERTED OVER A NON-MEDTRONIC (COOK MEDICAL LUNDERQUIST) GUIDEWIRE THROUGH THE 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH. THE FIRST DEPLOYMENT ATTEMPT PLACED THE VALVE TOO DEEP ON THE LEFT CORONARY CUSP (LCC). THE VALVE WAS FULLY RECAPTURED INTO THE DCS. THE DCS WAS MANIPULATED IN AN ATTEMPT TO POSITION THE DCS MORE ON THE OUTER CURVE OF THE AORTIC ARCH. UPON THE SECOND DEPLOYMENT, THE VALVE WAS FULLY DEPLOYED; HOWEVER, IT "DROPPED" TO 4MM ON THE NON-CORONARY CUSP (NCC) AND 10MM ON THE LCC. THE VALVE FRAME HAD A CONSTRAINED APPEARANCE. A POST-IMPLANT BALLOON DILATION WAS PERFORMED USING A 28MM NON-MEDTRONIC (NUMED) BALLOON. THE MEAN AORTIC GRADIENT WAS 12MM HG. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED WITH NO ANOMALY NOTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND REVEALED MILD-MODERATE PARAVALVULAR LEAK (PVL). THE PVL PROGRESSED TO SEVERE; ON THE SECOND POST-OPERATIVE DAY THE VALVE WAS EXPLANTED AND A SURGICAL AORTIC VALVE WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT AFTER THE 10X40MM NON-MEDTRONIC (ABBOTT ARMADA 35) BALLOON WAS USED FOR PRE-IMPLANT DILATION, THE 18MM NON-MEDTRONIC (NUMED) BALLOON WAS INSERTED TO PERFORM A SERIAL BALLOON DILATION OF THE NATIVE AORTIC VALVE WITH A LARGER BALLOON. THE NON-MEDTRONIC (NUMED) BALLOON RUPTURED DUE TO BALLOON SIZING AND PATIENT ANATOMY; HOWEVER, THE SITE DID NOT REPORT THE BALLOON WAS OVERFLATED. AFTER THE BALLOON RUPTURED, REMNANTS OF THE BALLOON WERE REMOVED. AT THE START OF VALVE DEPLOYMENT, THE STARTING POINT WAS NEAR THE BOTTOM OF THE PIGTAIL CATHETER AT A TARGET IMPLANT DEPTH OF 2-3MM. UPON FULL DEPLOYMENT, BUT PRIOR TO THE VALVE DISLODGEMENT, THE VALVE DEPTH WAS 4MM ON THE NCC AND 6MM ON THE LCC. THE PATIENT HAD A CALCIUM SCORE OF 8500, WHICH CONTRIBUTED TO THE CONSTRAINED APPEARANCE IN THE VALVE FRAME.
IT WAS REPORTED PRIOR TO A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE REPLACEMENT PROCEDURE, THE PATIENT WAS INTUBATED. VASCULAR ACCESS WAS ACHIEVED VIA THE RIGHT FEMORAL ARTERY. TEMPORARY TRANSVENOUS PACING WAS INITIATED AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION. AT THE START OF THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A 28MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON WAS INSERTED AND NAVIGATED TO THE HEART FOR A PRE-IMPLANT BALLOON DILATION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE AORTIC VALVE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND REPLACED WITH A 10X40MM NON-MEDTRONIC (ABBOTT ARMADA 35) BALLOON. FOLLOWING THE PRE-IMPLANT BALLOON DILATION, THE 18MM NON-MEDTRONIC (NUMED) BALLOON RUPTURED. WHEN THE 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH WAS WITHDRAWN FROM THE PATIENT, NO REMNANTS OF THE RUPTURED PORTION OF THE BALLOON WAS IN THE SHEATH. A NEW 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH WAS INSERTED INTO THE PATIENT. A 22MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON WOULD NOT CROSS THE AORTIC VALVE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND A SMALLER 20MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON SUCCESSFULLY CROSSED THE AORTIC VALVE AND A PRE-IMPLANT BALLOON DILATION WAS PE RFORMED. THEN A SERIAL DILATION WAS PERFORMED WITH NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOONS: A 22MM FOLLOWED BY A 28MM. THE 18FR MEDTRONIC INLINE SHEATH AND DELIVERY CATHETER SYSTEM (DCS) WERE INSERTED OVER A NON-MEDTRONIC (COOK MEDICAL LUNDERQUIST) GUIDEWIRE THROUGH THE 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH. THE FIRST DEPLOYMENT ATTEMPT PLACED THE VALVE TOO DEEP ON THE LEFT CORONARY CUSP (LCC). THE VALVE WAS FULLY RECAPTURED INTO THE DCS. THE DCS WAS MANIPULATED IN AN ATTEMPT TO POSITION THE DCS MORE ON THE OUTER CURVE OF THE AORTIC ARCH. UPON THE SECOND DEPLOYMENT, THE VALVE WAS FULLY DEPLOYED; HOWEVER, IT "DROPPED" TO 4MM ON THE NON-CORONARY CUSP (NCC) AND 10MM ON THE LCC. THE VALVE FRAME HAD A CONSTRAINED APPEARANCE. A POST-IMPLANT BALLOON DILATION WAS PERFORMED USING A 28MM NON-MEDTRONIC (NUMED) BALLOON. THE MEAN AORTIC GRADIENT WAS 12MM HG. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED WITH NO ANOMALY NOTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND REVEALED MILD-MODERATE PARAVALVULAR LEAK (PVL). THE PVL PROGRESSED TO SEVERE; ON THE SECOND POST-OPERATIVE DAY THE VALVE WAS EXPLANTED AND A SURGICAL AORTIC VALVE WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED TO REPORT AFTER THE 10X40MM NON-MEDTRONIC (ABBOTT ARMADA 35) BALLOON WAS USED FOR PRE-IMPLANT DI LATION, THE 18MM NON-MEDTRONIC (NUMED) BALLOON WAS INSERTED TO PERFORM A SERIAL BALLOON DILATION OF THE NATIVE AORTIC VALVE WITH A LARGER BALLOON. THE NON-MEDTRONIC (NUMED) BALLOON RUPTURED DUE TO BALLOON SIZING AND PATIENT ANATOMY; HOWEVER, THE SITE DID NOT REPORT THE BALLOON WAS OVERFLATED. AFTER THE BALLOON RUPTURED, REMNANTS OF THE BALLOON WERE REMOVED. AT THE START OF VALVE DEPLOYMENT, THE STARTING POINT WAS NEAR THE BOTTOM OF THE PIGTAIL CATHETER AT A TARGET IMPLANT DEPTH OF 2-3MM. UPON FULL DEPLOYMENT, BUT PRIOR TO THE VALVE DISLODGEMENT, THE VALVE DEPTH WAS 4MM ON THE NCC AND 6MM ON THE LCC. THE PATIENT HAD A CALCIUM SCORE OF 8500, WHICH CONTRIBUTED TO THE CONSTRAINED APPEARANCE IN THE VALVE FRAME.
IT WAS REPORTED PRIOR TO A TRANSCATHETER AORTIC BIOPROSTHETIC VALVE REPLACEMENT PROCEDURE, THE PATIENT WAS INTUBATED. VASCULAR ACCESS WAS ACHIEVED VIA THE RIGHT FEMORAL ARTERY. TEMPORARY TRANSVENOUS PACING WAS INITIATED AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION. AT THE START OF THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, A 28MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON WAS INSERTED AND NAVIGATED TO THE HEART FOR A PRE-IMPLANT BALLOON DILATION; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE AORTIC VALVE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND REPLACED WITH A 10X40MM NON-MEDTRONIC (ABBOTT ARMADA 35) BALLOON. FOLLOWING THE PRE-IMPLANT BALLOON DILATION, THE 18MM NON-MEDTRONIC (NUMED) BALLOON RUPTURED. WHEN THE 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH WAS WITHDRAWN FROM THE PATIENT, NO REMNANTS OF THE RUPTURED PORTION OF THE BALLOON WAS IN THE SHEATH. A NEW 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH WAS INSERTED INTO THE PATIENT. A 22MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON WOULD NOT CROSS THE AORTIC VALVE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND A SMALLER 20MM NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOON SUCCESSFULLY CROSSED THE AORTIC VALVE AND A PRE-IMPLANT BALLOON DILATION WAS PE RFORMED. THEN A SERIAL DILATION WAS PERFORMED WITH NON-MEDTRONIC (BECTON, DICKINSON AND COMPANY TRUE) BALLOONS: A 22MM FOLLOWED BY A 28MM. THE 18FR MEDTRONIC INLINE SHEATH AND DELIVERY CATHETER SYSTEM (DCS) WERE INSERTED OVER A NON-MEDTRONIC (COOK MEDICAL LUNDERQUIST) GUIDEWIRE THROUGH THE 22FR NON-MEDTRONIC (GORE MEDICAL DRYSEAL) SHEATH. THE FIRST DEPLOYMENT ATTEMPT PLACED THE VALVE TOO DEEP ON THE LEFT CORONARY CUSP (LCC). THE VALVE WAS FULLY RECAPTURED INTO THE DCS. THE DCS WAS MANIPULATED IN AN ATTEMPT TO POSITION THE DCS MORE ON THE OUTER CURVE OF THE AORTIC ARCH. UPON THE SECOND DEPLOYMENT, THE VALVE WAS FULLY DEPLOYED; HOWEVER, IT "DROPPED" TO 4MM ON THE NON-CORONARY CUSP (NCC) AND 10MM ON THE LCC. THE VALVE FRAME HAD A CONSTRAINED APPEARANCE. A POST-IMPLANT BALLOON DILATION WAS PERFORMED USING A 28MM NON-MEDTRONIC (NUMED) BALLOON. THE MEAN AORTIC GRADIENT WAS 12MM HG. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED WITH NO ANOMALY NOTED. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED AND REVEALED MILD-MODERATE PARAVALVULAR LEAK (PVL). THE PVL PROGRESSED TO SEVERE; ON THE SECOND POST-OPERATIVE DAY THE VALVE WAS EXPLANTED AND A SURGICAL AORTIC VALVE WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2866799 | EVOLUT FX PLUS VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC MEXICO S. DE R.L. DE CV | EVFXPLUS-34 | 00763000957377 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R| L |